Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

February 24, 2010 updated by: AstraZeneca

Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults

To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion Criteria:

  • Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
  • Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Candesartan cilexetil 16mg monotherapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Names:
  • Atacand
Experimental: 2
Candesartan cilexetil 16mg/HCT combination therapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Names:
  • Atacand
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg
Other Names:
  • HCTZ
  • Diazide
Active Comparator: 3
candesartan cilexetil 32mg monotherapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Names:
  • Atacand
Experimental: 4
Candesartan Cilexetil 32 mg/HCT combination therapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Names:
  • Atacand
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Names:
  • Atacand
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg
Other Names:
  • HCTZ
  • Diazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
Time Frame: 4 weeks
Mean of the changed DBP from baseline after 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
Time Frame: 4 weeks
Mean of the changed SBP from baseline after 4 weeks
4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy
Time Frame: 4 weeks
Percent of the patients achieving goal DBP and SBP after 4 weeks
4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy
Time Frame: 8 weeks
Percent of patients achieving goal of DBP
8 weeks
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
Time Frame: 8 weeks
Changed SBP from baseline after 8 weeks
8 weeks
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
Time Frame: 8 weeks
Change of hs-CRP from basline after 8 weeks
8 weeks
Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)
Time Frame: 8 weeks
Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
8 weeks
Compliance Levels at 4 Weeks and 8 Weeks of Therapy
Time Frame: 8 weeks
Percent of the number of returened pills to the number of prescrited pills
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Dong Hoon Choi, Severance Hospital
  • Study Director: Joonwoo Bahn, AstraZeneca Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2452L00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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